Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
NCT ID: NCT02970968
Last Updated: 2024-08-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2016-11-30
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
NCT01149369
Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study
NCT01934192
Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis
NCT05270460
Evaluation of Single Doses of GSK962040 in Critically Ill Patients With Enteral Feed Intolerance
NCT01039805
Domperidone for Chronic Nausea and Vomiting
NCT02757534
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study is divided into two phases: the screening phase and the evaluation phase. The screening phase includes a screening visit to evaluate subjects' preliminary eligibility for the study. During the screening phase, subjects will collect diary data for at least 4 weeks. The evaluation phase includes 4 weeks of randomized double-blind treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study Drug
VLY-686 (Tradipitant) oral capsule for 4 weeks.
VLY-686 (Tradipitant)
oral capsule
Placebo
Placebo oral capsule for 4 weeks.
Placebo
placebo oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VLY-686 (Tradipitant)
oral capsule
Placebo
placebo oral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects must agree to the use of contraception
3. Ability and acceptance to provide written informed consent;
4. Willing to participate in the pharmacogenomics sample collection;
5. Willing and able to comply with all study requirements and restrictions
6. Willing to not participate in any other interventional trial for the duration of their participation.
Exclusion Criteria
2. Pregnancy or nursing;
3. History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
4. Use of another NK1 antagonist or palonosetron;
5. Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
6. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vanda Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanda Investigational Site
Dothan, Alabama, United States
Vanda Investigational Site
Huntsville, Alabama, United States
Vanda Investigational Site
Tucson, Arizona, United States
Vanda Investigational Site
Little Rock, Arkansas, United States
Vanda Investigational Site
Chula Vista, California, United States
Vanda Investigational Site
Los Angeles, California, United States
Vanda Investigational Site
Palo Alto, California, United States
Vanda Investigational Site
San Francisco, California, United States
Vanda Investigational Site
Jacksonville, Florida, United States
Vanda Investigational Site
Largo, Florida, United States
Vanda Investigational Site
Miami, Florida, United States
Vanda Investigational Site
Athens, Georgia, United States
Vanda Investigational Site
Elgin, Illinois, United States
Vanda Investigational Site
Indianapolis, Indiana, United States
Vanda Investigational Site
Louisville, Kentucky, United States
Vanda Investigational Site
Marrero, Louisiana, United States
Vanda Investigational Site
Chevy Chase, Maryland, United States
Vanda Investigational Site
Boston, Massachusetts, United States
Vanda Investigational Site
Boston, Massachusetts, United States
Vanda Investigational Site
Wyoming, Michigan, United States
Vanda Investigational Site
Minneapolis, Minnesota, United States
Vanda Investigational Site
Pascagoula, Mississippi, United States
Vanda Investigational Site
St Louis, Missouri, United States
Vanda Investigational Site
Great Neck, New York, United States
Vanda Investigational Site
New York, New York, United States
Vanda Investigational Site
Raleigh, North Carolina, United States
Vanda Investigational Site
Salisbury, North Carolina, United States
Vanda Investigational Site
Huber Heights, Ohio, United States
Vanda Investigational Site
Mentor, Ohio, United States
Vanda Investigational Site
Tulsa, Oklahoma, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, United States
Vanda Investigational Site
Chattanooga, Tennessee, United States
Vanda Investigational Site
Jackson, Tennessee, United States
Vanda Investigational Site
Nashville, Tennessee, United States
Vanda Investigational Site
El Paso, Texas, United States
Vanda Investigational Site
Houston, Texas, United States
Vanda Investigational Site
Richardson, Texas, United States
Vanda Investigational Site
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Carlin JL, Lieberman VR, Dahal A, Keefe MS, Xiao C, Birznieks G, Abell TL, Lembo A, Parkman HP, Polymeropoulos MH. Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Jan;160(1):76-87.e4. doi: 10.1053/j.gastro.2020.07.029. Epub 2020 Jul 18.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VP-VLY-686-2301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.